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Job Responsibilities 工作職責(zé)： 1.Participate in analytical method development, qualification and method transfer and draft report; conduct biochemical analysis, including Residual HCP, hcHCDNA, ProteinA testing and Insulin, etc. 參與生化檢測(cè)的分析方法開發(fā)，確認(rèn)和方法轉(zhuǎn)移以及撰寫報(bào)告；進(jìn)行生化分析，包括殘留HCP、hcHCDNA、Protein A和胰島素等； 2.Per SOPs, perform routine analysis of process development samples from MSAT, GMP samples, including in-process samples. 根據(jù)SOP執(zhí)行MSAT 和GMP 樣品的常規(guī)分析，包括中控樣品等； 3.Participate in the development and of protein-protein interaction measurement, impurity determination and method optimization. Independent completion of protein binding measurement and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments. 參與蛋白質(zhì)藥物的結(jié)合分析、殘留物分析的方法開發(fā)及優(yōu)化, 獨(dú)立完成抗體藥物的蛋白結(jié)合力分析，包括各類生物分子結(jié)合能力實(shí)驗(yàn)； 4.Participate in the preliminary research and development of biopharmaceutical evaluation, biological stability analysis, participate in the writing of stability research reports and comparability reports. 參與前期研發(fā)的生物藥藥性評(píng)估，產(chǎn)品穩(wěn)定性研究分析，參與撰寫穩(wěn)定性研究報(bào)告和可比性報(bào)告； 5.Perform analytical data analysis, data review and trending analysis. 負(fù)責(zé)數(shù)據(jù)分析，數(shù)據(jù)審核和趨勢(shì)分析； 6.Communicate effectively with the company’s internal and external departments to successfully complete the project on time. 與公司內(nèi)外各部門進(jìn)行有效溝通，順利推動(dòng)項(xiàng)目按時(shí)完成； 7.Other work arranged by superior leaders. 上級(jí)領(lǐng)導(dǎo)安排的其他工作。